Direct-to-Consumer Advertising of Androgen Replacement Therapy

Abstract

The Kefauver-Harris Amendment to the Food, Drug and Cosmetic Act, enacted by Congress in 1962, required pharmaceutical manufacturers to provide proof of prescription drug effectiveness as well as safety and to obtain preapproval of their marketing plans. Over the next 35 years, manufacturers promoted their products largely to physicians through ads in medical journals and in-office “detailing.” Print advertising directed toward patients was unusual and broadcast advertising was rare, owing to the US Food and Drug Administration’s (FDA’s) insistence that ads on television and radio include a brief summary of adverse reactions and contraindications—a requirement that tended to produce long, stultifying, and expensive commercials. However, 20 years ago in 1997, the FDA ruled that “adequate provision” of information about drug risks and benefits could be made by referring consumers to a toll-free telephone number, a simultaneously occurring print ad, or a website. With barriers vastly diminished, this new FDA rule unleashed a torrent of television ads